Consumer Product Recalls

Hazard: Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Hazard: Medical device software marketed without FDA clearance .

Hazard: Medical device software marketed without FDA clearance .

Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Hazard: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

Hazard: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

Hazard: There is a leakage issue associated with the tubing in the manifold of the instrument.

Hazard: Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Hazard: Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

Hazard: The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

Hazard: An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.

Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.